i-STAT hs Ctni

Hi Christina,

We are going to be mirroring our main lab that uses HS troponin on the Siemens Atellica analyzer. 

We haven't put anything into stone yet and our CMO, CMIO, and Medical Directors are weighing their options and such, but we are leaning towards using the 99th%tile listing for gender-based reporting (13.0 ng/L for females and 28.0 ng/L for males) with critical values of anything above the upper limits of "normal" being considered as critical values. According to an Abbott source, the method has only been evaluated for the determination of AMI with no indications for ACS or "gray-zone" reporting. Our current (certainly subject to change) source of information is the 510(k) submission (K240984) and the current iteration of the IFU (both attached).

hs-TnI IFU 793033-00_A.pdf

hsTroponin-I 510k K240984.pdf

Does anyone have the Performance Verification Protocol from Abbott yet?

Have yall seen the QC and Calibration Verification Material storage requirements? It’s frozen. Also, CAP does not have a PT for this cartridge yet. 

It appears that the American Proficiency Institute (API; https://ppt.api-pt.com/Default.aspx) carries a hs-Troponin-I challenge. At this point, I do not know if it covers the iSTAT version or not. I've included the program information and API's contact information.

CAP does not have a high sensitivity troponin iSTAT proficiency testing program. They said that they are currently in the process of adding this program, but it's not yet completed. They also said that the HCRT and HCRTI are not compatible with iSTAT. I will need to check with Abbott to see what they recommend.